Tykerb

What is Tykerb?

Tykerb is a prescription medicine used:

• with the medicine capecitabine to treat people with breast cancer that is advanced or that has spread to other parts of the body (metastatic), and:
  • that is HER2-positive (tumors that produce large amounts of a protein called human epidermal growth factor receptor-2), and
  • who have already had certain other breast cancer treatments
    Before taking Tykerb with capecitabine, your breast cancer should have gotten worse (progressed) with the medicine trastuzumab.
• with the medicine letrozole to treat women who:
  • have gone through the change of life (postmenopausal), and
  • who have metastatic breast cancer that is hormone receptor-positive, HER2-positive, and hormonal therapy is a treatment option for them.

It is not known if Tykerb is safe and effective in children.

Who should not take Tykerb?

Do not take Tykerb if you are allergic to any of the ingredients in Tykerb. A complete list of ingredients in Tykerb can be found at the end of this Patient Information.

What should I tell my healthcare provider before taking Tykerb?

Before taking Tykerb, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have liver problems. You may need a lower dose of Tykerb.

For females, tell your healthcare provider if you:

• are pregnant or plan to become pregnant. Tykerb can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start taking Tykerb. You should use effective birth control (contraception) during treatment with Tykerb and for 1 week after the last dose of Tykerb. Tell your healthcare provider right away if you become pregnant during treatment with Tykerb.
• are breastfeeding or plan to breastfeed. It is not known if Tykerb passes into your breast milk. You should not breastfeed during treatment with Tykerb and for 1 week after the last dose of Tykerb. Talk to your healthcare provider about the best way to feed your baby if you breastfeed.

For males with female partners who are able to become pregnant:

• use effective contraception during treatment with Tykerb and for 1 week after the last dose.
• if your female partner becomes pregnant during treatment with Tykerb, tell your healthcare provider right away.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tykerb may affect the way other medicines work, and other medicines may affect the way Tykerb works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. Do not take other medicines during treatment with Tykerb without first talking with your healthcare provider.

How should I take Tykerb?

• Take Tykerb exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of Tykerb if needed.
• For people with advanced or metastatic breast cancer, Tykerb and capecitabine are taken in 21-day cycles. The usual dose of Tykerb is 1,250 mg (5 tablets) taken by mouth all at the same time, 1 time a day on days 1 to 21.
• Your healthcare provider will tell you the dose of capecitabine you should take and when you should take it.
• Take capecitabine with food or within 30 minutes after food.
• For people with hormone receptor-positive, HER2-positive breast cancer, Tykerb and letrozole are taken every day. The usual dose of Tykerb is 1,500 mg (6 tablets) taken by mouth all at the same time, 1 time a day. Your healthcare provider will tell you the dose of letrozole you should take and when you should take it.
• Take Tykerb at least 1 hour before, or at least 1 hour after a meal.
• Avoid eating or drinking grapefruit products during treatment with Tykerb.
• If you miss a dose of Tykerb, take your next dose at your regular time the next day.
• If you take too much Tykerb, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Tykerb?

Tykerb may cause serious side effects, including:

• heart problems, including decreased pumping of blood from the heart and an abnormal heartbeat. Signs and symptoms of an abnormal heartbeat include:
  • feeling like your heart is pounding or racing
  • dizziness
  • tiredness
  • feeling lightheaded
  • shortness of breath
    Your healthcare provider should check your heart function before you start taking Tykerb and during treatment.
• liver problems. Liver problems can be severe and deaths have happened. Signs and symptoms of liver problems include:
  • itching
  • yellowing of your skin or the white part of your eyes
  • dark urine
  • pain or discomfort in the right upper stomach area
    Your healthcare provider should do blood tests to check your liver before you start taking Tykerb and during treatment.
• diarrhea. Diarrhea is common with Tykerb and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and some deaths have happened. Call your healthcare provider right away if you have a change in bowel pattern or if you have severe diarrhea. Follow your healthcare provider’s instructions for what to do to help prevent or treat diarrhea.
• lung problems. Symptoms of a lung problem with Tykerb include a cough that will not go away or shortness of breath.
• severe skin reactions. Tykerb may cause severe skin reactions. Tell your healthcare provider right away if you develop a skin rash, red skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever, or any combination of these. As severe skin reactions can be life-threatening, your healthcare provider may tell you to stop taking Tykerb.

Call your healthcare provider right away if you have any of the signs or symptoms of the serious side effects listed above.

Common side effects of Tykerb in combination with capecitabine or letrozole include:

• diarrhea
• red, painful hands and feet
• nausea
• rash
• vomiting
• inflamed mouth, digestive tract and airways
• mouth sores
• headache
• unusual hair loss or thinning
• shortness of breath
• dry skin
• itching
• tiredness
• painful arms, legs and back
• loss of appetite
• indigestion
• nose bleeds
• nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles
• difficulty sleeping

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tykerb. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also get side effects from the other medicines taken with Tykerb. Talk to your healthcare provider about possible side effects you may get during treatment.

General information about the safe and effective use of Tykerb

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tykerb for a condition for which it was not prescribed. Do not give Tykerb to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tykerb that is written for health professionals.

How should I store Tykerb?

• Store Tykerb at room temperature between 68°F and 77°F (20°C and 25°C).
• Do not keep medicine that is out of date or that you no longer need.

Keep Tykerb and all medicines out of the reach of children.

What are the ingredients in Tykerb?

Active ingredient: Lapatinib.

Inactive ingredients: Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Coating: Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.

For more information, call 1-888-669-6682 or go to www.tykerb.com.